Key Responsibilities:
Leading NPI activity including all tests, qualifications, WI needed to approve the new production line.
Perform validations and update procedures
Support production and solve ongoing technical problems.
Improve existing equipment and technology.
Design and build jigs/small production aids.
Allocate needs, specify the solution.
Lead new equipment and technology projects from end to end, including specification, allocating an appropriate supplier, execute FAT, create qualification protocols (IQ, OQ, PQ), and execute the tests, WI, training the employees till full implementation in production.
Qualifications (Education, Skills, and Experience; Required):
BSc. In Mechanical Engineer or similar degree
Proved experience of minimum 3 years.
Experience in using CAD software such as SOLIDWORKS, Pro E or similar – advantage.
Experience in a medical production company. Experience with disposable’s medical device manufacturing –advantage.
Familiarity with GMP, ISO and FDA requirements.
Experience with ECR/ECO, equipment, and production lines qualification, writing WI and maintenance WI.
Team player.
Results driven – brings a sense of urgency.
Self-driven.
Good English – speaking and writing.
NPI engineer
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113675
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Job Details
Job Details
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Seniority | מתחיל | |
Type | משרה מלאה | |
Location | אביאל | |
Category | NPI |